• Title/Summary/Keyword: Multicenter clinical study

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Calcific tendinitis of the shoulder in the Korean population: demographics and its relation with coexisting rotator cuff tear

  • Yoo, Yon-Sik;Park, Jin-Young;Kim, Myung-sun;Cho, Nam-Su;Lee, Yong-Beom;Cho, Seung-Hyun;Park, Kyoung Jin;Cho, Chul-Hyun;Lee, Bong Gun;Shin, Dong Joo;Kim, Han-Hoon;Lim, Tae Kang
    • Clinics in Shoulder and Elbow
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    • v.24 no.1
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    • pp.21-26
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    • 2021
  • Background: To evaluate the demographics, clinical and radiographic features of calcific tendinitis of the shoulder in the Korean population, specifically focusing on the incidence of coexisting rotator cuff tear. Methods: Between October 2014 and January 2015, we performed a prospective multicenter study with 506 patients from 11 training hospitals in Korea. We collected data of demographics and radiographic analysis based on simple radiographs, clinical assessments based on visual analog scale (VAS) and the American Shoulder Elbow Surgeons (ASES) score, and treatment modalities that are used currently. We also evaluated coexisting rotator cuff tear by ultrasonography (US) or magnetic resonance imaging (MRI) images. Results: There were 402 female patients (79%) with mean age of 55 years (range, 31-87 years). Mean duration of symptoms was 16 months. Mean size of calcific materials was 11.4 mm (range, 0-35 mm). Mean value of VAS and ASES scores were 6.5 (range, 1-10) and 47 (range, 8-95), respectively. Of 383 patients (76%), 59 (15%) had rotator cuff tear including 15 full-thickness tears on US or MRI. Patients with rotator cuff tears were significantly associated with older age, recurrent symptoms, menstrual disorders in females, and having undergone calcification removal surgery and rotator cuff repair (all p<0.05). Conclusions: This study reported demographic, radiographic, and clinical features of calcific tendinitis of the shoulder in Korean population, which were not different from those of Western population. Coexisting rotator cuff tear was found with 15% incidence in this large series, suggesting that further radiographic study to evaluate rotator cuff tear might be needed in some calcific tendinitis patients of older age and presenting with recurrent symptoms.

Study on the Effects of Sasang Psychobiological Factors on General Health Status (일반건강특성에 영향을 미치는 사상체질의 심리적, 신체적 요인에 대한 연구)

  • Chae, Han;Kim, Yun Hee;Park, Soo Hyun;Hwang, Eui Hyoung;Kwon, Young Kyu;Lee, Soo Jin
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.28 no.4
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    • pp.452-459
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    • 2014
  • The purpose of this study was to examine the correlation between general health condition and biopsychological traits of Sasang typology which determines the disease susceptibility and treatment responses. We had Korean Constitutional Multicenter Bank (KCMB) listed 1156 participants for measuring Sasang Personality Questionnaire (SPQ) and Body Mass Index (BMI) for biopsychological traits of each Sasang types as well as Short Form 12 (SF12) for general health status. All the analysis was performed with consideration of gender and age. We analyzed the differences in general health status between Sasang types and the correlation between general health status and biopsychological traits of Sasang typology. We also analyzed how much the selected SF12 subscales can be explained with biopsychosocial characteristics. There were no generaliszable differences among Sasang type groups in SF12, no significant correlation between biopsychological traits and SF12 Physical and Mental Component Summary. We found that there were significant correlations between SPQ-Behavior subscale and SF12 Vitality, and the regression model with SPQ-Behavior, SPQ-Emotionality, age and sex can predict 15.4% of the total variances in SF12 Vitality. We discussed the possibility that the Sasang typology is not a determinant of general health status but a moderator for the susceptibility and response. This study would contribute to the development of Sasang type-specific life nurturing program focusing on the psychological perspectives.

A Novel Implantable Cerebrospinal Fluid Reservoir : A Pilot Study

  • Byun, Yoon Hwan;Gwak, Ho Shin;Kwon, Ji-Woong;Kim, Kwang Gi;Shin, Sang Hoon;Lee, Seung Hoon;Yoo, Heon
    • Journal of Korean Neurosurgical Society
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    • v.61 no.5
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    • pp.640-644
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    • 2018
  • Objective : The purpose of this pilot study was to examine the safety and function of the newly developed cerebrospinal fluid (CSF) reservoir called the V-Port. Methods : The newly developed V-Port consists of a non-collapsible reservoir outlined with a titanium cage and a connector for the ventricular catheter to be assembled. It is designed to be better palpated and more durable to multiple punctures than the Ommaya reservoir. A total of nine patients diagnosed with leptomeningeal carcinomatosis were selected for V-Port insertion. Each patient was followed up for evaluation for a month after the operation. Results : The average operation time for V-Port insertion was 42 minutes and the average incision size was 6.6 cm. The surgical technique of V-Port insertion was found to be intuitive by all neurosurgeons who participated in the pilot study. There was no obstruction or leakage of the V-Port during intrathecal chemotherapy or CSF drainage. Also, there were no complications including post-operative intracerebral hemorrhage, infection and skin problems related to the V-Port. Conclusion : V-Port is a safe and an easy to use implantable CSF reservoir that addresses problems of other implantable CSF reservoirs. Further multicenter clinical trial is needed to prove the safety and the function of the V-Port.

Multicenter Evaluation of Patients with Cutaneous Malignant Melanoma in Turkey: MELAS Study

  • Uysal-Sonmez, Ozlem;Tanriverdi, Ozgur;Esbah, Onur;Uyeturk, Ummugul;Helvaci, Kaan;Bal, Oznur;Yalcintas-Arslan, Ulku;Budakoglu, Burcin;Oksuzoglu, Berna
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.1
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    • pp.533-537
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    • 2013
  • Background: Malignant melanoma is a cancer that demonstrates rapid progression and atypical clinically features with a poor prognosis. Aim: This study was performed to determine the clinical characteristics and treatment outcomes of patients with malignant melanoma in Turkey. Methods: The medical records of 98 patients between 2007-2012 at our centers were retrieved from the patient registry. Overall survival (OS) was calculated using the Kaplan-Meier method. Results: In our study, with the median follow-up of all patients with cutaneous MM of 46.3 months, the median OS rate of all cases was 43.6 months and 5-year OS was 48.6%. However, five-year OS rates of patients with localized disease (stage I-II) and node involvement (stage III) were 60.3% and 39.6%, respectively. The median OS of stage IV patients was 8.7 months and 1-year OS rate was 26.2%. We showed that advanced stage, male gender, and advanced age in all patients with MM were significant prognostic factors of OS. Conclusions: Compared with the results of current studies from Western countries, we found similar findings concerning demographical features, histological variables and survival analyses for our patients with cutaneous MM in Turkey.

Outcome of complete acellular dermal matrix wrap with polyurethane implant in immediate prepectoral breast reconstruction

  • Naemonitou, Foteini;Mylvaganam, Senthurun;Salem, Fathi;Vidya, Raghavan
    • Archives of Plastic Surgery
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    • v.47 no.6
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    • pp.567-573
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    • 2020
  • Background Polyurethane implants have been used on and off in breast reconstruction since 1991 while prepectoral breast reconstruction has gained popularity in recent times. In this study, we present our outcomes from the use of acellular dermal matrix (ADM) complete wrap with polyurethane implants in prepectoral breast reconstruction. Methods This is a retrospective review of prospectively maintained database from 41 patients receiving complete ADM wrap with prepectoral polyurethane implants over a 3-year period. Selection criteria were adapted from a previous study (4135 Trust Clinical Audit Database) evaluating prepectoral reconstruction with Braxon matrices. Patient demographics, operative data, surgical complications, and outcomes were collected and analyzed. Results A total of 52 implant reconstructions were performed in 41 patients with a mean follow-up of 14.3 months (range, 6-36 months). The overall reported complication rates including early (less than 6 weeks) and late complications. Early complications included two patients (4.9%) with wound dehiscence. One of which had an implant loss that was salvageable. Another patient (2%) developed red-breast syndrome and two women (4.9%) developed with seroma treated conservatively. Late complications included one patient (2%) with grade II capsular contraction, 12 patients with grade I-II rippling and two patients (4.9%) with grade III rippling. Conclusions We present our experience of prepectoral polyurethane implant using complete ADM wrap. This is one of the few papers to report on the outcome of the prepectoral use of polyurethane in immediate implant-based breast reconstruction. Our early observational series show satisfactory outcome and long-term results are warranted by a large multicenter study.

Effect of loading time on the survival rate of anodic oxidized implants: prospective multicenter study

  • Kim, Seok-Gyu;Yun, Pil-Young;Park, Hyun-Sik;Shim, June-Sung;Hwang, Jung-Won;Kim, Young-Kyun
    • The Journal of Advanced Prosthodontics
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    • v.4 no.1
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    • pp.18-23
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    • 2012
  • PURPOSE. The purpose of this prospective study was to evaluate the effect of early loading on survival rate or clinical parameter of anodic oxidized implants during the 12- month postloading period. MATERIALS AND METHODS. Total 69 implants were placed in 42 patients. Anodic oxidized implants (GS II, Osstem Cor., Busan, Korea) placed on the posterior mandibles were divided into two groups, according to their prosthetic loading times: test group (2 to 6 weeks), and control group (3 to 4 months). The implant survival rates were determined during oneyear postloading period and analyzed by Kaplan-Meier method. The radiographic peri-implant bone loss and periodontal parameters were also evaluated and statistically analyzed by unpaired t-test. RESULTS. Total 69 implants were placed in 42 patients. The cumulative postloading implant survival rates were 88.89% in test group, compared to 100% in control group (P<.05). Periimplant marginal bone loss (T: $0.27{\pm}0.54$ mm, C: $0.40{\pm}0.55$ mm) and periodontal parameters showed no significant difference between the groups (P>.05). CONCLUSION. Within the limitation of the present study, implant survival was affected by early loading on the anodic oxidized implants placed on posterior mandibles during one-year follow-up. Early implant loading did not influence peri-implant marginal bone loss, and periodontal parameters.

Determining Optimal Cut-off Score for the Braden Scale on Assessment of Pressure Injury for Tertiary Hospital Inpatients (상급종합병원 입원환자의 욕창발생 위험예측을 위한 Braden Scale의 타당도 검증)

  • Park, Sook Hyun;Choi, hyeyeon;Son, Youn-Jung
    • Journal of Korean Critical Care Nursing
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    • v.16 no.3
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    • pp.24-33
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    • 2023
  • Purpose : This study aims to establish an optimal cut-off score on the Braden scale for the assessment of pressure injury to detect pressure injury risks among inpatients in a South Korean tertiary hospital. Methods : This retrospective study used electronic medical records, from January to December 2022. A total of 654 patients were included in the study. Of these, 218 inpatients with pressure injuries and 436 without pressure injuries were classified and analyzed using 1:2 Propensity Score Matching (PSM), and the generalized estimating equation was performed using SPSS Version 26 and the R Machlt package program. Results : The cut-off value on the Braden scale for distinguishing pressure injury was 17 points, and the AUC (area under the ROC curve) was 0.531 (0.484-0.579). The sensitivity was 56.6% (45.5-67.7%) and the specificity was 69.7% (66.0-73.4%). With 17 points, the Braden scale cut-off distinguished those who had pressure injuries from those who did not at the time of admission (p < .03). In the pressure injury group, the Braden score on the day of the pressure injury was 14, with significant results in all subcategories except the moisture category. Conclusion : Our findings revealed that a cut-off value of 17 was optimal for predicting the risk of pressure injuries among tertiary hospital inpatients. Future studies should evaluate the optimal cut-off values in different clinical environments. Additionally, it is necessary to conduct multicenter large sample studies to verify the effectiveness of a 17 value in PI risk assessments.

Non-atrophic gastric mucosa is an independently associated factor for superficial non-ampullary duodenal epithelial tumors: a multicenter, matched, case-control study

  • Azusa Kawasaki;Kunihiro Tsuji;Noriya Uedo;Takashi Kanesaka;Hideaki Miyamoto;Ryosuke Gushima;Yosuke Minoda;Eikichi Ihara;Ryosuke Amano;Kenshi Yao;Yoshihide Naito;Hiroyuki Aoyagi;Takehiro Iwasaki;Kunihisa Uchita;Hisatomi Arima;Hisashi Doyama
    • Clinical Endoscopy
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    • v.56 no.1
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    • pp.75-82
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    • 2023
  • Background/Aims: The etiology of superficial non-ampullary duodenal epithelial tumors (SNADETs) remains unclear. Recent studies have reported conflicting associations between duodenal tumor development and Helicobacter pylori infection or endoscopic gastric mucosal atrophy. As such, the present study aimed to clarify the relationship between SNADETs and H. pylori infection and/or endoscopic gastric mucosal atrophy. Methods: This retrospective case-control study reviewed data from 177 consecutive patients with SNADETs who underwent endoscopic or surgical resection at seven institutions in Japan over a three-year period. The prevalence of endoscopic gastric mucosal atrophy and the status of H. pylori infection were compared in 531 sex- and age-matched controls selected from screening endoscopies at two of the seven participating institutions. Results: For H. pylori infection, 85 of 177 (48.0%) patients exhibited SNADETs and 112 of 531 (21.1%) control patients were non-infected (p<0.001). Non-atrophic mucosa (C0 to C1) was observed in 96 of 177 (54.2%) patients with SNADETs and 112 of 531 (21.1%) control patients (p<0.001). Conditional logistic regression analysis revealed that non-atrophic gastric mucosa was an independent risk factor for SNADETs (odds ratio, 5.10; 95% confidence interval, 2.44-8.40; p<0.001). Conclusions: Non-atrophic gastric mucosa, regardless of H. pylori infection status, was a factor independently associated with SNADETs.

Clinical and Genetic Features of Korean Inherited Arrhythmia Probands

  • Joo Hee Jeong;Suk-Kyu Oh;Yun Gi Kim;Yun Young Choi;Hyoung Seok Lee;Jaemin Shim;Yae Min Park;Jun-Hyung Kim;Yong-Seog Oh;Nam-Ho Kim;Hui-Nam Pak;Young Keun On;Hyung Wook Park;Gyo-Seung Hwang;Dae-Kyeong Kim;Young-Ah Park;Hyoung-Seob Park;Yongkeun Cho;Seil Oh;Jong-Il Choi;Young-Hoon Kim
    • Korean Circulation Journal
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    • v.53 no.10
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    • pp.693-707
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    • 2023
  • Background and Objectives: Inherited arrhythmia (IA) is a more common cause of sudden cardiac death in Asian population, but little is known about the genetic background of Asian IA probands. We aimed to investigate the clinical characteristics and analyze the genetic underpinnings of IA in a Korean cohort. Methods: This study was conducted in a multicenter cohort of the Korean IA Registry from 2014 to 2017. Genetic testing was performed using a next-generation sequencing panel including 174 causative genes of cardiovascular disease. Results: Among the 265 IA probands, idiopathic ventricular fibrillation (IVF) and Brugada Syndrome (BrS) was the most prevalent diseases (96 and 95 cases respectively), followed by long QT syndrome (LQTS, n=54). Two-hundred-sixteen probands underwent genetic testing, and 69 probands (31.9%) were detected with genetic variant, with yield of pathogenic or likely pathogenic variant as 6.4%. Left ventricular ejection fraction was significantly lower in genotype positive probands (54.7±11.3 vs. 59.3±9.2%, p=0.005). IVF probands showed highest yield of positive genotype (54.0%), followed by LQTS (23.8%), and BrS (19.5%). Conclusions: There were significant differences in clinical characteristics and genetic yields among BrS, LQTS, and IVF. Genetic testing did not provide better yield for BrS and LQTS. On the other hand, in IVF, genetic testing using multiple gene panel might enable the molecular diagnosis of concealed genotype, which may alter future clinical diagnosis and management strategies.

Intravenous patient-controlled analgesia hydromorphone combined with pregabalin for the treatment of postherpetic neuralgia: a multicenter, randomized controlled study

  • Huang, Ying;Xu, Chenjie;Zeng, Tao;Li, Zhongming;Xia, Yanzhi;Tao, Gaojian;Zhu, Tong;Lu, Lijuan;Li, Jing;Huang, Taiyuan;Huai, Hongbo;Ning, Benxiang;Ma, Chao;Wang, Xinxing;Chang, Yuhua;Mao, Peng;Lin, Jian
    • The Korean Journal of Pain
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    • v.34 no.2
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    • pp.210-216
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    • 2021
  • Background: Postherpetic neuralgia (PHN) is the most common complication of acute herpes zoster. The treatment of PHN remains a challenge for clinical pain management. Despite the effectiveness of anticonvulsants, antidepressants, and lidocaine patches in reducing PHN, many patients still face intractable pain disorders. In this randomized controlled study, we evaluated whether hydromorphone through intravenous patient-controlled analgesia (IV PCA) was effective in relieving PHN. Methods: Patients with PHN were randomly divided into two groups, one group received oral pregabalin with IV normal saline, another group received oral pregabalin with additional IV PCA hydromorphone for two weeks. Efficacy was evaluated at 1, 4, and 12 weeks after the end of the treatments. Results: Two hundred and one patients were followed up for 12 weeks. After treatment, numerical rating scale (NRS) score of patients in the hydromorphone group was significantly lower than that of the control group, and the difference of NRS scores between the two groups was statistically significant at 4 and 12 weeks after treatment. The frequency of breakthrough pain in the hydromorphone group was significantly lower than that in the control group 1 and 4 weeks after treatment. After treatment, the quality of sleep in the hydromorphone group was significantly improved compared with the control group. The most common adverse reactions in the hydromorphone group were dizziness and nausea, with no significant respiratory depression. Conclusions: IV PCA hydromorphone combined with oral pregabalin provides superior pain relief in patients with PHN, which is worthy of clinical application and promotion.